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Vaccines often underperform in Africa compared to high-income countries. Why vaccines do not work as well in Africa remains uncertain. Malnutrition likely plays a role. Our study objective is to assess whether iron deficiency anaemia in young women impairs their immune response to the COVID-19 vaccine, and whether iron treatment improves their response.
Group 1 (immediate iron treatment) will receive iron treatment before vaccination. Women in both groups will receive the 1st dose of the COVID-19 vaccine. Vaccine response will be measured 28 and 56 days after the first vaccine administration in both groups. At 28 days, participants will receive the 2nd dose of the COVID-19 vaccine. Group 2 (delayed iron treatment) will receive iron treatment at study end.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate iron treatment | Active Comparator | intravenous iron carboxymaltose before vaccination |
|
| No iron treatment | No Intervention | no intravenous iron carboxymaltose before vaccination |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferinject | Dietary Supplement | intravenous iron carboxymaltose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibody titers | day 35 | |
| Antibody titers | day 63 | |
| Seroconversion | day 35 | |
| Seroconversion | day 63 | |
| Antibody avidity index | percentage of antibodies that remain bound to beads | day 35 |
| Antibody avidity index | percentage of antibodies that remain bound to beads | day 63 |
| Measure | Description | Time Frame |
|---|---|---|
| antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response | immunoassay | day 0 |
| antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response |
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Inclusion Criteria:
18-55 years old Zinc protoporphyrin > or equal 40 mmol/mol heme hemoglobin < or equal 109 g/L no malaria no known HIV infection no medical condition that precludes study involvement no iron supplementation 1 week prior to study start no recent tuberculosis infection no vaccination of yellow fever or influenza prior to enrolment not pregnant
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Simon Karanja, PhD | JKUAT Nairobi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Msambweni County Referral Hospital | Msambweni | Kwale County | Kenya |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
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immunoassay |
| day 7 |
| antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response | immunoassay | day 35 |
| antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response | immunoassay | day 63 |
| immune cell populations | number and type of immune cells | day 0 |
| immune cell populations | number and type of immune cells | day 7 |
| immune cell populations | number and type of immune cells | day 35 |
| immune cell populations | number and type of immune cells | day63 |
| Proteomics | Proteins involved in immune response | day 0 |
| Proteomics | Proteins involved in immune response | day 7 |
| Proteomics | Proteins involved in immune response | day 35 |
| Proteomics | Proteins involved in immune response | day 63 |
| Transcriptomics | Genes involved in immune response | day 0 |
| Transcriptomics | Genes involved in immune response | day 7 |
| Transcriptomics | Genes involved in immune response | day 35 |
| Transcriptomics | Genes involved in immune response | day 63 |
| Immune cell cytokine secretion | ELISpot | day 7 |
| Immune cell cytokine secretion | ELISpot | day 35 |
| Hemoglobin | iron status parameter | day 0 |
| Hemoglobin | iron status parameter | day 7 |
| Hemoglobin | iron status parameter | day 35 |
| Hemoglobin | iron status parameter | day 63 |
| Plasma ferritin | iron status parameter | day 0 |
| Plasma ferritin | iron status parameter | day 7 |
| Plasma ferritin | iron status parameter | day 35 |
| Plasma ferritin | iron status parameter | day 63 |
| Transferrin receptor | iron status parameter | day 0 |
| Transferrin receptor | iron status parameter | day 7 |
| Transferrin receptor | iron status parameter | day 35 |
| Transferrin receptor | iron status parameter | day 63 |
| Transferrin saturation | iron status parameter | day 0 |
| Transferrin saturation | iron status parameter | day 7 |
| Transferrin saturation | iron status parameter | day 35 |
| Transferrin saturation | iron status parameter | day 63 |
| C-reactive protein | inflammation status parameter | day 0 |
| C-reactive protein | inflammation status parameter | day 7 |
| C-reactive protein | inflammation status parameter | day 35 |
| C-reactive protein | inflammation status parameter | day 63 |
| Alpha-glycoprotein | inflammation status parameter | day 0 |
| Alpha-glycoprotein | inflammation status parameter | day 7 |
| Alpha-glycoprotein | inflammation status parameter | day 35 |
| Alpha-glycoprotein | inflammation status parameter | day 63 |
| retinol binding protein | vitamin A status marker | day 0 |
| retinol binding protein | vitamin A status marker | day 7 |
| retinol binding protein | vitamin A status marker | day 35 |
| retinol binding protein | vitamin A status marker | day 63 |
| plasma zinc | day 35 |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |